(131 days)
Not Found
No
The device description and performance studies focus on physical separation based on sperm motility, with no mention of AI/ML or related concepts.
No
The device is described as a "Sperm Separation Device" intended for preparing motile sperm for use in fertility treatments, not for directly treating a medical condition itself.
No
The device is described as a sperm separation device, intended for preparing motile sperm for use in fertility treatments. Its function is to separate and process semen samples based on sperm motility, not to diagnose a condition.
No
The device description clearly outlines a physical device with a base and filter layers used for separating sperm based on mobility. The performance studies focus on physical characteristics like sterilization, packaging integrity, and the device's ability to improve sperm motility, not software performance.
Based on the provided information, the LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states that the devices are for "preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures." These procedures involve the manipulation and analysis of biological samples (semen) outside of the body to provide information for medical purposes (treating infertility).
- Device Description: The description details how the device processes a biological sample (semen) to separate motile sperm. This processing of a biological sample is a key characteristic of an IVD.
- Performance Studies: The performance studies involve testing the device's ability to process semen samples and measure the resulting sperm motility. This type of testing on biological samples is consistent with IVD evaluation.
While the device itself is a physical separation tool and doesn't involve image processing or AI, its function is to prepare a biological sample for subsequent diagnostic or therapeutic procedures related to infertility. This places it squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
Product codes
MOK
Device Description
The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm. The LensHooke Sperm Separation Device has a base and filter layers to separate and process the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port. The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10-6. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing has been performed on the LensHooke CAO and CA1 Sperm Separation Devices:
- Sterilization Validation Study per ISO 11137-1:2006
- Transportation Simulation Study per ISTA 3A (2018)
- Package integrity testing following accelerated aging per ASTM F1980-21 to support a 2-year shelf-life:
- Dye penetration testing per ASTM F1929-15
- Seal strength testing Per ASTM F88/F88M-15
- Endotoxin testing per USP and ANSI/AAMI ST72:2019:
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
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October 31, 2022
Bonraybio Co., LTD. % Feng-Yu Lee Principal Regulatory Consultant IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212 San Juan Capistrano, CA 92675
Re: K221810
Trade/Device Name: LensHooke CA0 Sperm Separation Device LensHooke CA1 Sperm Separation Device Regulation Number: 21 CFR§ 884.6160 Regulation Name: Assisted reproduction labware Regulatory Class: II Product Code: MOK Dated: September 28, 2022 Received: September 29, 2022
Dear Feng-Yu Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221810
Device Name
LensHooke CA0 Sperm Separation Device LensHooke CA1 Sperm Separation Device
Indications for Use (Describe)
The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K221810 Page 1 of 4
Image /page/3/Picture/1 description: The image contains the logo for Bonraybio. The logo consists of a teal-colored circle with a white plant-like design inside, followed by the text "bonraybio" in a sans-serif font. The text is in a dark gray color and is positioned to the right of the circular icon.
510(K) Summary K221810
Submitter/Correspondent: 1
-
1.1 Submitter:
BonrayBio Co., Ltd. 4F., No.118, Gongye 9th Rd., Dali Dist., Taichung City 41280, Taiwan Contact Person: Clare Huang TEL: +886-4-24912385 FAX: +886-4-24912885 -
1.2 Submission Correspondent:
IVDD Regulatory Consultant 29122 Rancho Viejo Road, Suite 212, San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee TEL: 1-949-218-0929 FAX: 1-949-218-0928 -
1.3 Date Summary Prepared: October 27, 2022
2 Subject Device:
| Proprietary Name: | LensHooke CA0 Sperm Separation Device
LensHooke CA1 Sperm Separation Device |
|--------------------|--------------------------------------------------------------------------------|
| Common Name: | Sperm Separation Device |
| Regulation Name: | Assisted Reproduction Labware |
| Regulation Number: | 884.6160 |
| Product Code: | MQK |
| Regulatory Class: | II |
3 Predicate Device:
ZyMōt Multi Sperm Separation Device (850µl, 3 mL) Device Company: DxNow, Inc. 510(k) Number: K173075
The predicate device has not been subject to a design-related recall.
4 Device Description
The LensHooke CA0 Sperm Separation Device and LensHooke CA1 Sperm Separation Device are used to prepare motile sperm from semen based on the mobility of motile sperm.
The LensHooke Sperm Separation Device has a base and filter layers to separate and process
4
Image /page/4/Picture/1 description: The image contains the logo for "bonraybio". The logo consists of a circular icon on the left and the company name on the right. The icon features a stylized plant or leaf design in a light blue color, enclosed within a circle of the same color. The company name, "bonraybio", is written in a sans-serif font in a dark gray color.
the semen sample. The LensHooke Sperm Separation Device has two models, CA0 with one filter layer and CA1 with two filter layers. Liquefied semen (1 mL) is added to the base and sperm washing medium is added to the filter via a filter port. After incubation, the separated sperm are collected from the filter layer via the filter port.
The subject devices are radiation-sterilized with a sterility assurance level (SAL) of 10 °. The LensHooke Sperm Separation Devices are individually packaged and for single-use only.
5 Indications for Use
The LensHooke CA0 Sperm Separation Device and the LensHooke CA1 Sperm Separation Device are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
6 Comparison of Intended Use and Technological Characteristics with the Predicate Device:
| | LensHooke® CA0 and CA1
Sperm Separation Device
(Subject Device) | ZyMōt Multi Sperm Separation Device
(850 µL, 3 mL)
(Predicate Device - K173075) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LensHooke CA0 Sperm Separation Device
and the LensHooke CA1 Sperm Separation
Device are intended for preparing motile
sperm from semen for use in the treatment
of infertile couples by intracytoplasmic sperm
injection (ICSI), in vitro fertilization (IVF) and
intrauterine insemination (IUI) procedures. | The ZyMōt Multi Sperm Separation
Device is intended for preparing motile
sperm from semen for use in the
treatment of infertile couples by
intracytoplasmic sperm injection (ICSI),
in vitro fertilization (IVF) and
intrauterine insemination (IUI)
procedures. |
| Design | A disposable device containing a base, filter
layer(s), and a port on the filter for media
loading and sperm collection after
processing.
- CA0 with one filer layer
- CA1 with two filter layers | ZyMōt Multi – A disposable culture
dish containing a separation chamber
and an inlet port. The separation
chamber has a lower sample chamber
and an upper collection chamber. The
two chambers are separated by a
microporous filter. |
| Mechanism of
action | Liquefied semen is added to the base. The
filter(s) are placed on the base and
separation medium added through the layer
port.
The loaded device is incubated at 37°C for
30 minutes to allow motile sperm to swim up
and across the filter(s) to migrate into the
separation medium in the upper filter layer. | ZyMōt Multi - The semen is added to
the inlet port to fill the lower sample
chamber; then, the separation
medium is added to the upper
collection chamber.
The loaded device is incubated at 37°C
for 30 minutes to allow motile sperm
to swim up and cross the filter to
migrate into the over-laying
separation medium in the upper
collection chamber |
5
Image /page/5/Picture/1 description: The image contains the logo for Bonraybio. The logo consists of a circular icon on the left and the company name "bonraybio" on the right. The icon features a stylized wheat stalk inside a light blue circle, while the company name is written in a simple, sans-serif font.
| Material | Polycarbonate | Polymethylmethacrylate, polycarbonate, flash-spun high-density polyethylene fibers |
|---|---|---|
| Human Sperm | ||
| Survival Testing | ≥80% of the control motility at 24 hours after exposure for 30 minutes | ≥80% of the control motility at 24 hours after exposure for 30 minutes |
| Endotoxin | ≤20 EU/device | ≤2.5 EU/device |
| Sterile | Yes | Yes |
| Shelf-Life | 24 months | 12 months |
The subject and predicate devices have the same indications for use and intended use. The subject device and predicate device have the same fundamental design incorporating a chamber for loading semen, a filter for motile sperm to migrate through, and a port for collection of motile sperm. However, there are technological differences between the subject and predicate devices, including the number of filters, materials, endotoxin specifications, and shelf-life duration). These differences do not raise different questions of safety and effectiveness.
7 Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows :
The following testing has been performed on the LensHooke CAO and CA1 Sperm Separation Devices:
- Sterilization Validation Study per ISO 11137-1:2006
- Transportation Simulation Study per ISTA 3A (2018)
- Package integrity testing following accelerated aging per ASTM F1980-21 to support a 2-year shelf-life:
- o Dye penetration testing per ASTM F1929-15
- Seal strength testing Per ASTM F88/F88M-15 O
- Endotoxin testing per USP and ANSI/AAMI ST72:2019: